GMP Validation Lead: Quality & Compliance Expert

Proclinical Consulting; Oberwallis; Vor Ort; CHF 120.000 - 190.000; Vollzeit

Zusammenfassung

Proclinical is seeking a QA Validation Manager to oversee and ensure compliance of critical GMP processes with product requirements, process parameters, and global regulatory guidelines in Switzerland. You will collaborate with Manufacturing and clients, act as QA SME for validation documentation (Process Validation, Cleaning Validation, CSV) and lead CPV, change controls, deviations, and investigations.

Applicants must have rights to work in the location and a degree in science or biotech;

Qualifikationen

• Experience with GMP validation activities and regulatory expectations.
• Knowledge of biotechnological manufacturing and low bioburden environments.
• Strong English; German language skills are a plus.
• Experience with CSV is desirable.

Aufgaben

• Oversee validation activities to ensure GMP compliance.
• Act as QA point of contact for validation projects and strategies.
• Review SOPs, protocols, reports, change controls, deviations, and other GMP records.
• Support product transfers and validation strategies.
• Participate in audits and inspections under European and US FDA guidelines.
• Contribute to continuous improvement initiatives.
• Lead CPV and process validation activities.
• Support data integrity programs.

Kenntnisse

Process validation

Cleaning validation

Equipment & system qualification

Change control

Deviation management

Non-conformity investigations

Risk assessments

Data integrity

SOP review/approval

CSV understanding

Ausbildung

Degree in Science, Biotechnology, or related field

Jobbeschreibung

Proclinical is seeking a QA Validation Manager to oversee and ensure compliance of critical GMP processes with product requirements, process parameters, and global regulatory guidelines in Switzerland. You will collaborate with Manufacturing and clients, act as QA SME for validation documentation (Process Validation, Cleaning Validation, CSV) and lead CPV, change controls, deviations, and investigations.

Applicants must have rights to work in the location and a degree in science or biotech;